Biotechnological production of pharmaceutical active substances needs ancillary substances for various purposes. Detergents are used at the end of the synthesis phase to lyse the producing cells, to liberate the synthesis products for purification, and as a protection against viral or bacterial contamination. After purification of desired products, growth media and buffers used in product purification are inactivated and drained to the wastewater. Such discharges may cause environmental concern as estimated by environmental risk assessment (ERA) for detergent.
Current protocols for the inactivation of virus in biotechnical production of pharmaceutical active substances often rely on the use of Triton X-100. A degradation product of Triton X-100 is octlyphenol, an ecotoxin with demonstrated estrogenic effects. Defined limits for octylphenol discharge is 0.01 to 0.1 ppb. As such, the use of Triton-X in biotechnological processes may require the use of complex and costly means to remove octylphenol from wastestreams. What is needed is an environmentally compatible detergent for use in production of biologics.
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